The Addition of rTMS to the Therapy of Adolescents That Suffer From Treatment Resistant Depression: An Open Label Study
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Adolescent Depression
- Sponsor
- Shalvata Mental Health Center
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Child Depression Rating Scale (CDRS) comparison before after therapy
- Last Updated
- 14 years ago
Overview
Brief Summary
The investigators hypothesis that repetitive transcranial Stimulation (rTMS) is a safe and effective add-on therapy for resistent depression in adolescent patients.
A group of adolescents suffering from non psychotic major depression that was resistant to at least 2 drug trials and a trail of psychotherapy will be recruited. After an informed consent procedure for both parents and patients, patients will go through a clinical and cognitive evaluation. They will receive a protocol of 4 weeks (20 work days) of rTMS using the figure of 8 magstim coil at 100% threshold, 42 trains of 4 seconds each, intertrain interval of 30 sec to the LDPC, 1680 pulses per day. Then they will be reevaluated.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 15-18 years old
- •Right hand dominant
- •Suffering from major depression
- •CDRS \> 60
- •At least 3 months of current depressive episode
- •Failed 2 drug trials (or 3 drug trials if trial terminated prematurely due to side effects) and at least 1 course of psychotherapy
- •No contraindication for rtms (safety questionnaire)
- •No change in pharmacotherapy in the last month
Exclusion Criteria
- •Schizophrenia or psychotic symptoms
- •Hypertension
- •History of major head trauma
- •Metal implements in the head
- •History of neurosurgery
- •History of severe head migraine
- •History of hearing loss or sp cochlear transplantation
- •Pregnancy
- •Current drug abuse
- •Unstable medical condition
Outcomes
Primary Outcomes
Child Depression Rating Scale (CDRS) comparison before after therapy
Time Frame: 4 weeks